MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; STEM: CEMENTLESS, HA COATED STD

Model Number	01.12.024
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 december 2020: lot 091106: (b)(4) items manufactured and released on 25-jun-2009.Expiration date: 2014-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Additional devices involved: batch review performed on 15 december 2020: ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857)lot.090940.Lot 090940: (b)(4) items manufactured and released on 04-jun-2009.Expiration date: 2014-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Batch review performed on 15 december 2020: liner: versafitcup cc trio 01.26.3244hcat hooded pe hc fixed liner ø 32 / e (k103352)lot.082635.Lot 082635: (b)(4) items manufactured and released on 26-nov-2008.Expiration date: 2013-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.
Event or Problem Description
The patient presented to the hospital clinic with fever, 11 years after the primary surgery.Infection of the hip was found.Also shoulder (competitor product) was found infected.Wash out performed and liner and head replacement.Also shoulder washed out and replaced.Primary implants were well fixed and stable.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: STEM: CEMENTLESS, HA COATED STD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11138880
• Report Number: 3005180920-2021-00021
• Device Sequence Number: 16374472
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: 01.12.024
• Device Catalogue Number: 01.12.024
• Device Lot Number: 091106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR